Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 1200 - 1219)

WEDNESDAY 8 DECEMBER 2004

DR RICHARD KENNEDY, PROFESSOR ALLAN TEMPLETON AND PROFESSOR LESLEY REGAN

  Q1200  Dr Harris: I think it is in its remit.

  Professor Regan: It is very important.

  Q1201  Dr Harris: Can you be a bit more specific then?

  Professor Regan: It comes back to how your unit is assessed and where your clients come from, or your patients come from (whichever way you wish to look at it). At the end of the day, if you are given a sheet of paper and you say, "I wish to access in-vitro fertilisation and I am looking for the best place to go", and you look at the pregnancy rate per transfer you will get very different information than if you were to look at what were the successful pregnancy outcomes from that clinic. What we know is that there are higher pregnancy rates per transfer, it is thought, with multiple embryo transfer or two or three transfers.

  Professor Templeton: May I just say, in relation to this table, there are major reservations about data collection in some of the countries that are well above the United Kingdom. The denominator is a key issue. But if you look at singleton births, even somewhere as far ahead, apparently, of the United Kingdom as the US, the rates are the same.

  Q1202  Chairman: Are you saying that the data collection is rubbish in this country?

  Professor Templeton: Not in this country. It is the denominator data. In this country, as soon as an injection of gonadatrophine begins that cycle is registered. We think, probably, most are.

  Q1203  Chairman: So your defence about the league table is other countries do it badly?

  Professor Templeton: No, I am just saying that in certain other countries—and I would not want to name them—above the United Kingdom there, we know that data collection is confined to one or two clinics, and that still it is voluntary, so that the clinics do not have to submit their data.

  Q1204  Dr Harris: Is Sweden one of those countries?

  Professor Templeton: No, no. Sweden is certainly not one of those countries.

  Q1205  Mr Key: Is it Iceland?

  Professor Templeton: It is none of the Scandinavian countries.

  Q1206  Mr Key: So it is Greece? And Russia and Slovenia? On this point about funding, if you look at pregnancy rates per transfer in this table within the United Kingdom there are also enormous discrepancies between different IVF centres funding in different ways. Have you any evidence that the way in which the clinics are funded makes a difference? For example, quite a lot of the IVF clinics which are within NHS hospital premises are actually privately owned by companies which set up to specialise in this area, and the contract may or may not be with the hospital trust. Is there any evidence that that makes any difference, or accounts for the discrepancy?

  Dr Kennedy: I think it is quite clear, if we remove the commercialisation of IVF in this country, which undoubtedly has driven practice, and the league tables that have been produced, then we can move very quickly to more sensible clinical practice which is not driven by this desire to be up there in the league table but is there to serve our patients best, to reduce the adverse consequences (ie, multiple pregnancy) and to move to single embryo transfer in selective cases.

  Q1207  Dr Iddon: Professor Templeton, you or your organisation believe that the media and equipment used in IVF, particularly when new materials are introduced, should be regulated in some way. Who do you think should carry out that regulation?

  Professor Templeton: I think, again, it is the accreditation system, and I think that the standards set by the laboratory organisations in the context of assessing new media, and so on, should be set down in the accreditation system. So I think it should be done at that level; I do not think it is a matter for legislation, it is a matter for the code of practice or the accreditation system.

  Q1208  Dr Iddon: I am sorry, could I just be clear about who sets this code of practice? Your professional organisation?

  Professor Templeton: We would be very happy to contribute to such a code. If we were asked then I think the professional organisations could certainly evolve a code of practice by which clinics in this country could be accredited.

  Q1209  Chairman: If you were not asked, would you trust it?

  Professor Templeton: It would depend on who was doing it, I guess.[2]


  Q1210  Chairman: Is this a moral or ethical judgment?

  Professor Templeton: If you look at the present code of practice (I forget how many there are) there are six pages referring to counselling, and when I joined the HFEA in 1995 I was astonished that there was about half-a-page which referred to actual clinical practice in relation to egg recovery. At that time there were two recorded deaths in Greece from monitored egg recovery and yet there was nothing in the code. So there were distortions within the code of practice which referred to the origins of the HFEA. One of them was this overly need for counselling and the other was the welfare of the child assessment, with insufficient on clinical and laboratory standards of practice.

  Q1211  Dr Iddon: There are some clinicians who believe that success rates may be improved by using techniques like assisted hatching and blastocyst transfer. There are other clinicians who believe that that is of little benefit. What is the view of the College?

  Professor Templeton: The NICE guidelines reviewed both of these issues and the jury, I think, is certainly out on assisted hatching, but the overall indications from the evidence that can be gathered is that there is not major advantage. There may be subsections of patients but it has never been shown in these subsections that it is unquestionably efficacious. So I think there is an issue there. We have got bodies in this country that have the ability: NICE has two processes, it has the guidelines process and it has the HFEA process, and if we are unsure about new technologies they can be assessed in that way. You do not need specific organisations as such to do it; I think it is part of medical practice.

  Professor Regan: Could I just add, at this point, that the examples you cited were all to do with an IVF unit and the embryo transfer procedures. There are a limited number of units within the United Kingdom that are using multiple forms of additional therapies in order to improve, supposedly, pregnancy rates, none of which have been demonstrated in any randomised controlled trial to be of benefit and most of which, potentially, have very significant side-effects for the woman who has been given these medications. They include steroids, intravenous immunoglobin infusions, aspirin, heparin injections and a variety of other medications. It would be very helpful, I think, for the future if we were to consider these issues as well as those that are confined to an embryo and laboratory scenario, because they do have very, very significant implications. It is quite horrifying, I think, how many couples are advised to take these treatments because they are desperate and because they have no other way of knowing whether they should or should not, and they turn to the internet, which, as you will recognise, does not have peer reviewed information.

  Q1212  Dr Iddon: Do you think the present Act and/or the HFEA itself inhibits developments in clinical practice like the ones I have just mentioned?

  Professor Templeton: The only example I know where I think, in my view, there have been inappropriate inhibitions has been egg freezing. There has been an issue to do with safety and efficacy of egg freezing and certainly there was a very negative view taken by the then New Technology Committee of the HFEA. However, by and large, the look at new practice has been fair and has been balanced. You could say, of course, that had ICSI not been so well developed and carefully developed in Belgium we might still be talking about whether it was an appropriate thing to do in this country, and there is an issue there, but by and large I think new clinical developments are available in this country. Just compare with some other European countries where embryo freezing is not available, where PGD is not available, where ICSI even now is not available; I think the relevant new developments, by and large, have been made available.

  Q1213  Chairman: Is there not an international standards accreditation process?

  Professor Templeton: Not to my knowledge.

  Q1214  Chairman: ISO?

  Professor Templeton: No.

  Dr Kennedy: If you are talking about standard clinical practice, then the EU Directive will move us in that direction, very much so.

  Q1215  Chairman: So your view is that it has not even started yet?

  Dr Kennedy: It is starting but the EU Directive will not be applicable to United Kingdom centres until April 2006.

  Q1216  Dr Harris: Professor Templeton, do you think the Whittakers would agree with you that the HFEA—of which you are a member?

  Professor Templeton: Was, yes.

  Q1217  Dr Harris: Maybe you were involved in this decision. If so, please let me know. Do you think they would agree that the HFEA, other than in egg freezing, has not held back therapeutic advances?

  Professor Templeton: That is a difficult point, you would have to agree—very difficult. They would probably disagree but others still have their reservations about whether it is an appropriate way forward.

  Q1218  Dr Harris: Yes, but the HFEA told us that they changed their mind on that on the basis of scientific advance between the first decision and this decision.

  Professor Templeton: And they changed their mind on Diane Blood as well.

  Q1219  Dr Harris: Do you think science changed around the safety of PGD between the fist decision and the second decision, or was it the legal judgment that changed in the Court of Appeal on the Hashmi case?

  Professor Templeton: These are external influences that obviously make people change their minds, and that is all part of the richness of the discussion. It is unfortunate that individual patients are caught up in that decision—Diane Blood having to go abroad for her treatment and the Whittakers not getting treatment but another group getting it—but it is all part of that discussion and it should not be a static discussion.


2   Note by Dr Kennedy: The British Fertility Position is that the code of practice/clinical standards could be produced by the Professional Societies/relevant Royal College's. The imminent EU Directive will require a "quality standard" and a multidisciplinary group recently produced a draft quality standard for assisted reproduction units in the UK. Back


 
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